FDA 510(k)

离子透皮治疗电极

K号: K232020 · 2023-10-16

决定日期2023-10-16

产品代码EGJ

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Iontophoresis Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Top-Rank Health Care Co., Ltd.. It received FDA 510(k) clearance on 2023-10-16 under 510(k) number K232020. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Iontophoresis Electrodes?

Iontophoresis Electrodes is a medical device that received FDA 510(k) clearance on 2023-10-16. The listed applicant is Top-Rank Health Care Co., Ltd.. The 510(k) number is K232020.

When did Iontophoresis Electrodes receive FDA 510(k) clearance?

Iontophoresis Electrodes received FDA 510(k) clearance on 2023-10-16, under 510(k) number K232020.

Who is the listed applicant for Iontophoresis Electrodes?

The FDA 510(k) record lists Top-Rank Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iontophoresis Electrodes?

The FDA product code for Iontophoresis Electrodes is EGJ.

列明Top-Rank Health Care Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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